Synthetic corneal inlays

Abstract

This review is based on the activities of the Vision Cooperative Research Centre (previously Cooperative Research Centre for Eye Research and Technology) Corneal Implant team from 1991 to 2007. The development of a synthetic polymer of perfluoropolyether (PFPE), meeting essential physical and biological requirements, for use as a corneal inlay is presented. Each inlay was placed in a corneal flap created with a microkeratome and monitored over a two‐year period in a rabbit model. The results indicate that the PFPE implant shows excellent biocompatibility and biostability. As a result, a Phase 1 clinical trial is being conducted. Three years post‐implantation, the PFPE inlays are exhibiting continued excellent biocompatibility. Corneal inlays made from PFPE are biocompatible with corneal tissue in the long term and offer a safe and biologically‐acceptable alternative to other forms of refractive surgery.

Key words:

• additive refractive corneal procedure
• corneal implant
• corneal inlay
• perfluropolyether
• Phase 1 clinical trial

ACKNOWLEDGEMENTS

The authors would like to thank Denise and Robyn Lawler for their expert care of the animals involved in this study and Dr Srihdar for conducting the surgery in the Phase 1 clinical study.

We wish to acknowledge the work and efforts of the other members of the Vision CRC/CRCERT Corneal Implant Team, in alphabetical order, who have contributed to this project since it commenced:

Jim Bates, Danelle Beatie, Gerrit Beumer, Barbara Borjarski, Grace Chan, Hassan Chaouk, Ron Chatelier, Hanying Cheng, Ann Dalton, Tracey Davies, Paul Erickson, Mirella Fabbri, Marijan Filipic, Helen Fitton, Qian Garrett, Hans Griesser, Arthur Ho, Brien Holden, Xiaojuan Hao, Justine Jefferey, Michelle Jenkins, Graham Johnson, Nicola Kapo, Warren Knower, Jenny Lan, Bronwyn Laycock, Tam Le, Michele Madigan, Samantha Mayer, Gail McFarland, Elspeth McLachlan, Gordon Meijs, Jukka Moilanen, Xuan Nguyen, Ross O’Dell, Dan O’Leary, Indrani Perera, Andrea Peztnick, Therese Pham, John Ramshaw, Angela Ruffell, Klaus Schindhelm, Heather St John, Jack Steele, Lavinia Taliana, Sarah Taylor, Helmut Thissen, Simon Tout, Anne Underwood, Zoran Vasic, John Wilkie.

We are also grateful to Dr Wayne Hawthorne for access to and support with the studies involving Westrans pigs.